On 15 December 2020, Professor Anita Simonds, European Respiratory Society President, held a question and answer session about vaccines. Her answers to the questions are below. If you have any more questions about COVID-19 vaccines then please send them to firstname.lastname@example.org.
Why has the vaccine development been so quick when normal vaccine development can take 10 years?
There are a few reasons the COVID-19 vaccines have been produced quicker than the normal production process for vaccinations.
The initial design stage of the vaccine was quicker as existing information could be taken from work to find a vaccine for SARS and MERS – other forms of coronavirus.
Also, once the smaller studies were completed suggesting that the COVID-19 vaccines would generate a response in the body to fight the virus, companies took the chance to start making the vaccine in bulk. This would not normally happen because of the financial risk. However, given the grave situation of a worldwide pandemic, governments across the world were prepared to order the vaccine and say they would pay for it. This risk was therefore taken on by the public through their governments, meaning that companies could begin manufacturing much sooner than usual, ready for the vaccine to be rolled out once the larger trials were completed.
Another big change was that regulators usually wait until all phases of a vaccine trial have been completed so that they can review the evidence in one go. This time, companies have been providing data to the regulators throughout the process. They worked with them to ask what the regulator needed and delivered the data as the studies continued. This process of rolling feedback meant that regulators were in a much better position at the end of the trials to give an opinion straight away.
All studies were done in a rigorous and robust way – the science is as good as normal and no corners were cut in the development of the vaccine.
What are the requirements for regulators to approve a vaccine?
The main requirements are safety and efficacy – how safe the vaccine is and how effective it is. Companies also need to prove that each individual vaccine will be produced to the high standards seen in the trials.
One reason the COVID-19 vaccine is so exciting is because of how effective it was in the trials – its efficacy. The Pfizer/BioNtech vaccine was shown to have a 90% efficacy, the Moderna vaccine had a 94.5% efficacy, while the Oxford University/AstraZeneca vaccine was 70%.
Regulators usually aim for 50% efficacy for a vaccine. Sometimes vaccines that are used each year, such as the flu vaccine, can have much lower efficacy than this. The numbers of 70% and upwards are therefore very encouraging and better than many vaccine experts expected.
It is worth remembering that looking at the overall efficacy number on its own can be misleading – all these trials provide information on how the vaccine performed in different subgroups. We know that the elderly are vulnerable to COVID-19 so looking at the efficacy in the over 70s is also important.
How do we know if there are any long-term side-effects of the vaccine?
We only find out about the long-term effects of any vaccine once it is in general use in the population. The safety will be continuously monitored. Particular issues that are still to be considered are whether the vaccine is safe in pregnant or breastfeeding women, in people with severe illness and in children, and whether it interacts with other vaccines. There is no evidence yet that the vaccine is unsafe if you have already had COVID-19 or if it makes so-called Long-Covid any worse.
Which countries will receive the vaccine first?
Many countries have bought up supplies in advance – they have gambled and placed orders with different vaccines before regulators have approved them. The World Health Organization and Gavi – the vaccine alliance – have promised funding to low-income countries to ensure the vaccine will be distributed here at low-cost or no-cost. The Oxford University/AstraZeneca trial is the cheapest and easiest to distribute and when approved it will be provided cost-free to low-income countries.
Is there a European directive detailing who should get the vaccine first?
There is no European directive telling countries who they should give the vaccine to first. This will be organised country by country, but most will likely prioritise the elderly, especially those in care homes, those with underlying conditions and front-line healthcare workers.
Will the development of the COVID-19 vaccine change the vaccine development process moving forwards?
It is likely that vaccine development has now changed forever. We are already looking back and thinking how could it have taken this long. The big issue is the risk involved in the cost. Companies may only wish to produce a vaccine during a trial if the cost is covered by governments and this will depend on the seriousness of the issue.
Are we likely to be given a ‘vaccine passport’?
This will be a decision taken by individual countries, or airline companies. All countries will have the ability to record on patient records when a person has received the vaccine, but it is uncertain at the moment whether they will be given anything, such as a card or passport, to confirm this has happened.
Is the vaccine better at protecting us compared with the antibodies we get from being infected with COVID-19?
So far, the data suggests that the immune response generated from the vaccine is better than the immune response we get from being infected with COVID-19. This is particularly the case for older people – they are getting more antibodies from the vaccine than they appear to generate from fighting off the infection. As this is still a new disease, we don’t yet know if this will be the case long-term.
Do we need percentage of the population to be vaccinated before we reduce other infection control measures such as social distancing and face masks?
Many healthcare experts believe that our behaviour around infection control has changed forever. For example, people may feel more comfortable wearing face masks on crowded public transport moving forwards, particularly if they have a cold. Measures such as face masks, hand washing and distancing can help stop the spread of all respiratory viruses and therefore these measures may always be useful, particularly in winter seasons.
We don’t yet know what percentage of the population need to have immunity to COVID-19 before it becomes manageable. At the moment, if the vaccine roll-out continues as expected, we are likely to see some of the government-enforced restrictions easing from the middle of 2021 onwards.
Will the vaccine work with mutated versions of the virus?
Viruses mutate, that’s what they do. Largely these mutations won’t require a change in the vaccine as the part of the virus that the vaccines target is unlikely to change from a mutation. However, if this does happen, the vaccines that have been developed can by modified quickly if they need to target a new mutation. This happens every year with the flu vaccine.